Stryker Endoscopy - PneumoSure - Class 2 Recall
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - da Vinci S Surgical System - Class 2 Recall
da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery an...
Source: Medical Device Recalls - April 13, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - da Vinci S Surgical System - Class 2 Recall
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of mic...
Source: Medical Device Recalls - April 13, 2016 Category: Medical Equipment Source Type: alerts
Applied Medical Resources Corp - GK213, AME Standard Kit - Class 2 Recall
STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2016 Category: Medical Equipment Source Type: alerts
Applied Medical Resources Corp - Epix Universal Clip Applier - Class 2 Recall
CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2016 Category: Medical Equipment Source Type: alerts
Applied Medical Resources Corp - GK260, Standard Set - Class 2 Recall
STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2016 Category: Medical Equipment Source Type: alerts
Applied Medical Resources Corp - GK258, AME Standard Kit - Class 2 Recall
STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2016 Category: Medical Equipment Source Type: alerts
Covidien Medical Products (Shanghai) Manufacturing L.L.C. - Covidien Emprint Ablation System - Class 2 Recall
Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures (...
Source: Medical Device Recalls - March 18, 2016 Category: Medical Equipment Source Type: alerts
